Home › NCT07801066

Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer

A Prospective, Randomized, Single-blind, Study to Assess Drowsiness, Cognition, Fall Risk, and Electroencephalographic (EEG) Dynamics After Oral Metaxalone Tablets 640 mg (M640) Versus Metaxalone 800 mg in Healthy Participants

Who can join

Ages 18 to 55 · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* Healthy adults aged 18 to 55 years old
* Weigh at least 120 pounds
* Medically healthy
* Able to sign and date informed consent form

Exclusion Criteria:

* Current use of any medications known to affect the sleep-wake cycle
* Sleep disorder diagnosis
* Positive urine test for drugs
* Known history of alcohol use disorder
* Having a history of cognitive disorders, depression, schizophrenia, panic disorder, or dementia
* Having difficulty eating high fat meal
* Participants who are pregnant, nursing or intending to become pregnant during the period of study.
* Blood Pressure \> 160/110 or \<90/50 mmHg.
* Heart Rate \>100 or \< 50/ beats per minute.
* Having a history of seizure disorder or epilepsy.

About the study

Health participants take a single dose, perform testing, washout for one week, take a single dose of different formulation, and perform testing for comparison of the 2 doses.

What is being tested

• Metaxalone 640 mg (drug)
• Metaxalone 800 MG (drug)

Sponsor: Primus Pharmaceuticals · Participants: 20 · Started: Oct 15, 2026

Contact the study team

• Project Manager · Phone: 480-483-1410
• Clinical Manager · Phone: 480-250-6689

Official record on ClinicalTrials.gov — NCT07801066

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.